TIDMAZN
RNS Number : 5205S
AstraZeneca PLC
06 November 2019
6 November 2019 14:00 GMT
Calquence data to show improved progression-free survival in
Phase III front-line chronic lymphocytic leukaemia trial at ASH
2019 Annual Meeting
Robust early-stage pipeline advancements and presentations
across
multiple scientific platforms demonstrate potential to
improve
treatment outcomes in blood cancers with high unmet need
AstraZeneca will present the first data from the Phase III
ELEVATE-TN trial assessing Calquence (acalabrutinib), a
next-generation selective Bruton's tyrosine kinase (BTK) inhibitor,
in patients with previously untreated chronic lymphocytic leukaemia
(CLL), as well as data from novel-combination trials across
multiple blood cancers at the 2019 American Society of Hematology
(ASH) Annual Meeting and Exposition in Orlando, USA, December
7-10.(1)
The Company will present over 30 abstracts, including seven oral
presentations, in CLL, mantle cell lymphoma (MCL), acute myeloid
leukaemia (AML), diffuse large B-cell lymphoma (DLBCL) and multiple
myeloma (MM). Key data include:
-- The first presentation of data from the pivotal Phase III
ELEVATE-TN trial evaluating Calquence in combination with
obinutuzumab and Calquence monotherapy versus obinutuzumab combined
with chlorambucil chemotherapy in previously untreated CLL
-- Long-term efficacy, safety and tolerability data on Calquence
in relapsed or refractory CLL from the Phase I/II ACE-CL-001
trial
-- First-time data on roxadustat as a potential new treatment
for anaemia in patients with primary myelodysplastic syndrome
(MDS)
Dave Fredrickson, Executive Vice President, Oncology Business
Unit said: "AstraZeneca continues to demonstrate its strength in
haematology, presenting new research at ASH that spans targeted
therapies across eight blood cancers. This year we are especially
excited to present the ELEVATE-TN data demonstrating the impressive
efficacy and tolerability of Calquence in 1st-line chronic
lymphocytic leukaemia."
Key headline data from the Calquence Phase III ELEVATE-TN
trial
Efficacy measure Calquence plus Calquence monotherapy Obinutuzumab
obinutuzumab N = 179 plus chlorambucil
N = 179 N = 177
Stratified analysis, median follow-up 28 months
Hazard ratio HR 0.10 HR 0.20 n/a
for PFS endpoint (primary endpoint) (secondary endpoint)
(vs. obinutuzumab
+ chlorambucil), 95% CI 0.13-0.30,
stratified analysis 95% CI 0.06-0.17, p<0.0001
P<0.0001
median not reached
median not reached median 22.6 months
-------------------- ---------------------- --------------------
Select adverse events (AEs) include infusion reactions, which
were less frequent with Calquence plus obinutuzumab (13%) than with
obinutuzumab plus chlorambucil (40%). Additionally, AEs led to
treatment discontinuation in 11% of patients on Calquence plus
obinutuzumab, 9% of patients on Calquence, and 14% of patients on
obinutuzumab plus chlorambucil. With >2 y of follow-up, 79% of
patients in both the Calquence-containing arms remain on Calquence
as a monotherapy. Other select AEs (Calquence plus obinutuzumab or
Calquence vs chlorambucil plus obinutuzumab) included atrial
fibrillation (any grade: 3% or 4% vs. 1%), bleeding (any
grade/Grade >=3: 43%/2% or 39%/2% vs. 12%/0%), and hypertension
(Grade >=3: 3% or 2% vs. 3%).
Full data from the ELEVATE-TN trial will be presented at ASH by
the primary investigators. AstraZeneca has submitted Calquence for
US regulatory review in 1st-line and relapsed/refractory CLL.
Raising the bar for CLL treatment outcomes with Calquence
In addition to the oral presentation of the ELEVATE-TN results,
key presentations include:
-- An oral presentation on preliminary data from a Phase II
investigator-initiated trial evaluating Calquence combined with
obinutuzumab and venetoclax in patients with previously untreated
CLL, including high-risk disease status and a trial-in-progress
poster detailing an ongoing Phase III trial to evaluate this novel
combination in patients with previously untreated CLL without
del(17p) or TP53 mutation.
-- Long-term (42-month) follow-up results from the Phase I/II
ACE-CL-001 trial confirming Calquence initial efficacy from this
trial for the treatment of relapsed or refractory CLL and providing
additional data on duration of response and long-term
tolerability.
Exploring a potential treatment option for a challenging
comorbidity in blood cancer
-- An oral presentation on first-time data from a global Phase
III trial evaluating roxadustat to treat anaemia in patients with
primary MDS. Considered a type of cancer, MDS is a group of diverse
bone marrow disorders in which the bone marrow does not produce
enough healthy blood cells. Approximately one in three MDS patients
can progress to AML.(2)
Exploring potential new medicines from the pipeline and new
treatment strategies for aggressive or treatment-resistant blood
cancers
-- In AML, an oral presentation and four poster presentations,
including results from an Imfinzi (durvalumab) and azacitidine
combination for the 1st-line treatment of older,
chemotherapy-ineligible patients and data from a Phase I/II
clinical trial of AZD2811(nanoparticles) as a monotherapy or in
combination with azacitidine in previously untreated or
relapsed/refractory patients who are not eligible for intensive
induction therapy.
-- In DLBCL, five abstracts, including a poster presentation
detailing the ongoing Phase I PRISM trial of Calquence in four
different combinations with potential new medicines targeting
STAT3, ATR, CD47 and BRD4.
-- In MM, three poster presentations, including results of a
Phase I trial of MEDI2228, a BCMA antibody-PBD conjugate and
potential new medicine, as a monotherapy and in combinations with
bortezomib and DNA-damage response medicines and results from an in
vitro trial of AZD4785 alone or with proteasome inhibitors
targeting mutant KRAS.
Key AstraZeneca presentations at ASH 2019
Sharman, J. ELEVATE TN: Phase 3 Study Oral Presentation
of Acalabrutinib Combined Saturday 7 December
with Obinutuzumab (O) or Alone 07:30 ET
vs O Plus Chlorambucil (Clb) Orange County Convention
in Patients (Pts) With Treatment-Naive Center, Hall D
Chronic Lymphocytic Leukemia
(CLL)
============================================= ============================
Lampson, BL. Preliminary Safety and Efficacy Oral Presentation
Results from a Phase 2 Study Saturday 7 December
of Acalabrutinib, Venetoclax 07:45 ET
and Obinutuzumab in Patients Orange County Convention
with Previously Untreated Center, Hall D
Chronic Lymphocytic Leukemia
(CLL)
============================================= ============================
Frei, CR. Treatment Patterns and Outcomes Oral Presentation
of 1205 Patients on Novel Monday 9 December
Agents in the US Veterans 15:15 ET
Health Administration (VHA) Orange County Convention
System: Results from Retrospective Center, Valencia A (W415A)
EMR and Chart Review Study
in the Real-World Setting
============================================= ============================
Goyal, RK. Overall Survival, Adverse Oral Presentation
Events, and Economic Burden Monday 9 December
in Medicare Patients with 15:15 ET
Chronic Lymphocytic Leukemia Orange County Convention
Receiving Cancer-Directed Center, Valencia A (W415A)
Therapy
============================================= ============================
Furman, RR. Acalabrutinib Monotherapy Poster Presentation
in Patients with Relapsed/Refractory Sunday 8 December
Chronic Lymphocytic Leukemia: 18:00 - 20:00 ET
42-Month Follow-Up of a Phase Orange County Convention
2 Study Center, Hall B
============================================= ============================
Brown, JR. A Phase 3 Trial Comparing Poster Presentation
the Efficacy and Safety of Monday 9 December
Acalabrutinib in Combination 18:00 - 20:00 ET
with Venetoclax with or without Orange County Convention
Obinutuzumab, Compared with Center, Hall B
Investigator's Choice of Chemoimmunotherapy
in Patients with Previously
Untreated Chronic Lymphocytic
Leukemia (CLL) without del(17p)
or TP53 Mutation
============================================= ============================
Mantle cell lymphoma
Kabadi, S. Overall Survival, Adverse Oral Presentation
Events, and Economic Burden Saturday 7 December
in Medicare-Insured Patients 08:00 ET
with Mantle Cell Lymphoma Orange County Convention
Receiving Cancer-Directed Center, W308
Therapy
Ryan, K. Characteristics of Mantle Poster Presentation
Cell Lymphoma (MCL) and Chronic Sunday 8 December
Lymphocytic Leukemia (CLL) 18:00 - 20:00 ET
Patients Treated with Acalabrutinib Orange County Convention
in a Real World Setting in Center, Hall B
the United States
============================================= ============================
Acute myeloid leukaemia
Zeidan, A. Efficacy and Safety of Azacitidine Oral Presentation
(AZA) in Combination with Monday 9 December
the Anti-PD-L1 Durvalumab 16:30 ET
(durva) for the Front-line Orange County Convention
Treatment of Older Patients Center, Chapin Theater
(pts) with Acute Myeloid Leukemia (W320)
(AML) Who Are Unfit for Intensive
Chemotherapy (IC) and Pts
with Higher-Risk Myelodysplastic
Syndromes (HR-MDS): Results
from a Large, International,
Randomized Phase 2 Study
============================================= ============================
Donnellan, A Phase I/II Study of AZD2811NP Poster Presentation
W. as Monotherapy or in Combination Monday 9 December
in Treatment-Naïve or 18:00 - 20:00 ET
R/R AML/MDS Patients Not Eligible Orange County Convention
for Intensive Induction Therapy Center, Hall B
============================================= ============================
Diffuse large B-cell lymphoma
Roschewski, PRISM: A Platform Protocol Poster Presentation
M. for the Treatment of Relapsed/Refractory Sunday 8 December
Aggressive Non-Hodgkin Lymphoma 18:00 - 20:00 ET
Orange County Convention
Center, Hall B
============================================= ============================
Moskowitz, Safety and Antitumor Activity
CH. Study of Loncastuximab Tesirine
and Durvalumab in Diffuse
Large B-Cell, Mantle Cell,
or Follicular Lymphoma
============================================= ============================
Multiple myeloma
Xing, L. Anti-BCMA PBD MEDI2228 combats Poster Presentation
drug resistance and synergizes Saturday 7 December
with bortezomib and inhibitors 17:30 - 19:30 ET
to DNA damage response in Orange County Convention
multiple myeloma Center, Hall B
============================================= ============================
Sacco, A. Specific targeting of KRAS Poster Presentation
using a novel high-affinity Sunday 8 December
KRAS antisense oligonucleotide 18:00 - 20:00 ET
in myeloma. Orange County Convention
Center, Hall B
============================================= ============================
Xing, L. MEDI2228, a novel BCMA antibody-PBD Poster Presentation
conjugate, sensitizes human Sunday 8 December
multiple myeloma cells to 18:00 - 20:00 ET
NK cell-mediated cytotoxicity Orange County Convention
and upregulates CD38 expression Center, Hall B
in MM cells: clinical implication
============================================= ============================
Primary MDS-induced anaemia
Henry, D. Roxadustat (FG4592; ASP1517; Oral Presentation
AZD9941) in the Treatment Monday 9 December
of Anemia in Patients with 16:30 - 18:00 ET
Lower Risk Myelodysplastic Orange County Convention
Syndrome (LR-MDS) and Low Center, W311ABCD
Red Blood Cell (RBC) Transfusion
Burden (LTB)
About ELEVATE-TN
ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label
Phase III trial evaluating the safety and efficacy of Calquence in
combination with obinutuzumab, a CD20 monoclonal antibody, or
Calquence alone vs. chlorambucil, a chemotherapy, in combination
with obinutuzumab in previously untreated patients with CLL. In the
trial, 535 patients were randomised (1:1:1) into three arms.
Patients in the first arm received chlorambucil in combination with
obinutuzumab. Patients in the second arm received Calquence (100mg
twice daily until disease progression or unacceptable toxicity) in
combination with obinutuzumab. Patients in the third arm received
Calquence monotherapy (100mg twice daily until disease progression
or unacceptable toxicity).(3)
The primary endpoint is progression-free survival (PFS) in the
Calquence and obinutuzumab arm compared to the chlorambucil and
obinutuzumab arm, assessed by an independent review committee
(IRC), and a key secondary endpoint is IRC-assessed PFS in the
Calquence monotherapy arm compared to the chlorambucil and
obinutuzumab arm. Other secondary endpoints include objective
response rate, time to next treatment and overall survival.(3)
About AstraZeneca in Haematology
Leveraging its strength in oncology, AstraZeneca has established
haematology as one of four key oncology disease areas of focus. The
Company's haematology franchise includes two US FDA-approved
medicines and a robust global development programme for a broad
portfolio of potential blood cancer treatments. Acerta Pharma
serves as AstraZeneca's haematology research and development arm.
AstraZeneca partners with like-minded science-led companies to
advance the discovery and development of therapies to address unmet
need.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of
new medicines that has the potential to transform patients'
lives and the Company's future. With at least six new medicines to
be launched between 2014 and 2020, and a broad pipeline
of small molecules and biologics in development, we are
committed to advance Oncology as one of AstraZeneca's four Growth
Platforms focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy, as illustrated by the investment in Acerta Pharma in
haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal and
Metabolism, and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca.
Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
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Michele Meixell US +1 302 885 2677
Investor Relations
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Henry Wheeler Oncology +44 203 749 5797
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US toll-free +1 866 381 72 77
References
1. Barf T, et al. Acalabrutinib (ACP-196): A Covalent Bruton
Tyrosine Kinase Inhibitor with a Differentiated Selectivity and In
Vivo Potency Profile. J Pharmacol Exp Ther. 2017;363 (2) 240-252.
Available online. Accessed October 2019.
2. American Cancer Society. What Are Myelodysplastic Syndromes?
Available online. Accessed October 2019.
3. ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab +
Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and
Acalabrutinib in Subjects With Previously Untreated CLL.
NCT02475681. Available online. Accessed October 2019.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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END
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